MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-12 for EFI TRAINING SYSTEM manufactured by Total Gym Global Corp.
[17562125]
The efi gravity training system machine was adjusted to the proper height for the pt. The therapist moved and tested the machine to insure it was in place. The pt laid down on the equipment and began to exercise and the machine fell from the inclined position to a flat position with the pt on it. The pt reported no injury or pain. Two parts of the machine were noted on the ground near the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025046 |
| MDR Report Key | 2539336 |
| Date Received | 2012-04-12 |
| Date of Report | 2012-04-12 |
| Date of Event | 2012-04-11 |
| Date Added to Maude | 2012-04-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFI TRAINING SYSTEM |
| Generic Name | GRAVITY TRAINING SYSTEM |
| Product Code | ION |
| Date Received | 2012-04-12 |
| ID Number | ACE#01019466 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOTAL GYM GLOBAL CORP |
| Manufacturer Address | 7755 ARGONS DR. SAN DIEGO CA 92126 US 92126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-12 |